Ignite Creation Date:
2025-12-24 @ 5:36 PM
Ignite Modification Date:
2026-01-24 @ 8:29 PM
Study NCT ID:
NCT01738568
Status:
COMPLETED
Last Update Posted:
2021-08-30
First Post:
2012-11-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Aging and Aerobic Exercise Training on Brain Glucose Metabolism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003704', 'term': 'Dementia'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2015-02-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-24', 'studyFirstSubmitDate': '2012-11-27', 'studyFirstSubmitQcDate': '2012-11-29', 'lastUpdatePostDateStruct': {'date': '2021-08-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-11-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-02-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Brain Glucose Uptake', 'timeFrame': '12 weeks', 'description': 'The investigators will assess brain glucose uptake using positron emission tomography at baseline and following 12-weeks of either aerobic exercise training or sedentary control period.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['High intensity aerobic training'], 'conditions': ['Dementia']}, 'referencesModule': {'references': [{'pmid': '29077855', 'type': 'DERIVED', 'citation': 'Robinson MM, Lowe VJ, Nair KS. Increased Brain Glucose Uptake After 12 Weeks of Aerobic High-Intensity Interval Training in Young and Older Adults. J Clin Endocrinol Metab. 2018 Jan 1;103(1):221-227. doi: 10.1210/jc.2017-01571.'}], 'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': "Aging is associated with a loss of brain function and conditions such as dementia and Alzheimer's disease. It is likely that decreased brain metabolism is contributing to the progression of age related degenerative diseases. Aerobic exercise training can increase brain volumes and is associated with decreased risk for degenerative brain conditions. However, little is know about the changes that occur to brain metabolism with aerobic training and aging."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Healthy sedentary adults aged 18-30 or 65-80 years of all ethnicities will be eligible. Pregnant women, children, prisoners or other at risk populations will not be recruited.\n\nInclusion Criteria:\n\n* Age 18-30 years or 65-80 years\n\nExclusion Criteria:\n\n* Body mass index (BMI) \\>31 kg/m2\n* Smoking\n* Pregnancy\n* Participation in structured exercise (\\>2 times per week for 30 minutes or longer)\n* Cardiovascular, metabolic (type 2 diabetes, fasting plasma glucose at or above 110 mg/dL and untreated hypo- or hyperthyroidism) or renal disease\n* Orthopedic problems that would keep them from being able to ride an exercise bicycle, lift weights or do a combination of these exercise\n* Medications that are known to impact on mitochondrial function: Corticosteroids, opiates, benzodiazepines, tricyclic antidepressants, beta blockers, sulfonylureas, insulin, anticoagulants, barbiturates, insulin sensitizers, fibrates (PPAR gamma agonist)\n* Claustrophobia'}, 'identificationModule': {'nctId': 'NCT01738568', 'briefTitle': 'Effects of Aging and Aerobic Exercise Training on Brain Glucose Metabolism', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Effect of Aging and Aerobic Exercise Training on Brain Glucose Metabolism', 'orgStudyIdInfo': {'id': '12-003357'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exercise', 'description': 'Aerobic exercise', 'interventionNames': ['Behavioral: High intensity aerobic training', 'Behavioral: Sedentary Control']}], 'interventions': [{'name': 'High intensity aerobic training', 'type': 'BEHAVIORAL', 'description': 'High intensity aerobic interval training will be performed 12-weeks. Exercise training will last 1 hour per day, 5 days per week and include high intensity interval cycling at \\~70-95% maximum workload for 4 minutes followed by 3 minutes of rest.', 'armGroupLabels': ['Exercise']}, {'name': 'Sedentary Control', 'type': 'BEHAVIORAL', 'description': 'Sedentary control participants will not perform any regular exercise for 12-weeks.', 'armGroupLabels': ['Exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Val Lowe, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PI', 'investigatorFullName': 'Val Lowe', 'investigatorAffiliation': 'Mayo Clinic'}}}}